Evidence map›Paper›PMID 26573223›Full record

ArticleClinical and translational science2015

Accrual Index: A Real-Time Measure of the Timeliness of Clinical Study Enrollment.

Lauren Corregano, Katelyn Bastert, Joel Correa da Rosa, Rhonda G Kost

Abstract read
In one paragraph

Article in Clinical and translational science, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Lauren CorreganoClinical Research Support Office, The Rockefeller University Center for Clinical and Translational Science, New York, New York, USA.
Katelyn BastertClinical Research Support Office, The Rockefeller University Center for Clinical and Translational Science, New York, New York, USA.
Joel Correa da RosaDepartment of Research Design and Biostatistics, The Rockefeller University Center for Clinical and Translational Science, New York, New York, USA.
Rhonda G KostClinical Research Support Office, The Rockefeller University Center for Clinical and Translational Science, New York, New York, USA.

Funding

Transforming Translational Science and Education to Benefit Human HealthUL1TR000043 · NCATS · ROCKEFELLER UNIVERSITY · PI COLLER, BARRY · 2012 to 2015
$26.8M
NCATS NIH HHS UL1 TR000043
6 · The paper itself

Abstract

backgroundAchieving timely accrual into clinical research studies remains a challenge for clinical translational research. We developed an evaluation measure, the Accrual Index (AI), normalized for sample size and study duration, using data from the protocol and study management databases. We applied the AI retrospectively and prospectively to assess its utility.

methodsAccrual Target, Projected Time to Accrual Completion (PTAC), Evaluable Subjects, Dates of Recruitment Initiation, Analysis, and Completion were defined. AI is (% Accrual Target accrued/% PTAC elapsed). Changes to recruitment practices were described, and data extracted from study management databases.

resultsDecember 2014 (or final) AI was analyzed for 101 studies initiating recruitment from 2007 to 2014. Median AI was ≥1 for protocols initiating recruitment in 2011, 2013, and 2014. The AI varied widely for studies pre-2013. Studies with AI > 4 utilized convenience samples for recruitment. Data-justified PTAC was refined in 2013-2014 after which the AI range narrowed. Protocol characteristics were not associated with study AI.

conclusionProtocol AI reflects the relative agreement between accrual feasibility assessment (PTAC), and accrual performance, and is affected by recruitment practices. The AI may be useful in managing accountability, modeling accrual, allocating recruitment resources, and testing innovations in recruitment practices.

Indexed as

Clinical Trials as TopicPatient SelectionHumansModels, StatisticalProspective StudiesRetrospective StudiesSample SizeTime FactorsTranslational Research, Biomedicalclinical research methodsclinical trialparticipant recruitment, clinical researchtranslational research

Identifiers

PMID26573223
PMCPMC4703441

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.